Bispecific CAR-T Cells for Blood Diseases

Age: Any Age
Sex: Any
Trial Phase: Phase 1
Sponsor: Roswell Park Cancer Institute
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new type of CAR-T cell therapy, a treatment that modifies a patient's immune cells to better fight cancer. The researchers aim to determine the safety of this treatment for individuals with aggressive blood cancers that have returned or not responded to previous treatments. It targets patients whose cancers exhibit specific markers, CD19 and CD20, common in certain blood cancers. Suitable candidates for this trial include those who have undergone at least one previous treatment for these blood cancers but still have detectable disease. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research in CAR-T cell treatments is still developing. As a Phase 1 trial, this study tests the treatment's safety for humans in its early stages. Researchers focus on how the body processes the treatment and potential side effects.

Specific safety information from past studies on the 20-19 Tan BB06z CAR T treatment is not yet available. Generally, CAR-T cell treatments can cause side effects like cytokine release syndrome, with symptoms such as fever and tiredness, or neurotoxicity, which affects the nerves. Trials closely monitor these side effects to ensure participant safety.

Participants in this trial will receive careful monitoring to manage any side effects, with the main goal of finding a safe dose for future research.12345

Why do researchers think this study treatment might be promising?

Unlike the standard of care for blood diseases, which often includes chemotherapy and monoclonal antibodies, the 20-19 Tan BB06z CAR T treatment is unique because it uses bispecific CAR-T cells. Most treatments target a single antigen, but this therapy targets two different antigens on cancer cells, potentially increasing its effectiveness. Researchers are excited because this dual-targeting approach could enhance the precision of cancer cell eradication while minimizing damage to healthy cells.

What evidence suggests that this treatment might be an effective treatment for blood diseases?

Research has shown that CAR-T cell therapy, like the 20-19 Tan BB06z treatment studied in this trial, holds promise for treating aggressive blood cancers. CAR-T cells are specially modified immune cells designed to better locate and destroy cancer cells. Studies have demonstrated that CAR-T therapies targeting CD19, a marker on cancer cells, can significantly reduce cancer in some patients. The 20-19 Tan BB06z treatment is unique because it targets both CD19 and CD20, another marker, potentially increasing its effectiveness by attacking cancer in two ways. Early results suggest this approach could improve outcomes for patients with hard-to-treat blood cancers. Participants in this trial will join a dose escalation study to determine the maximum tolerated dose of this treatment.678910

Who Is on the Research Team?

AN

Alex Niu, MD

Principal Investigator

Roswell Park Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for people with aggressive blood cancers that have come back or haven't responded to treatment, and whose cancer cells test positive for CD19. Participants must meet certain health requirements set by the study team.

Inclusion Criteria

I still have signs of cancer before getting CAR-T cell treatment.
My Burkitt lymphoma did not respond to or came back after chemotherapy.
My kidneys are working well enough for treatment.
See 18 more

Exclusion Criteria

I have had serious heart rhythm problems or fainted for unknown reasons.
Pregnant or lactating patients
I have had a heart attack in the past 6 months.
See 12 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive different doses of 20-19 Tan BB06z CAR T cells to determine the maximum tolerated dose

up to 2 years

Follow-up

Participants are monitored for safety, toxicity, and effectiveness after CAR T cell infusion

up to 2 years

What Are the Treatments Tested in This Trial?

Interventions

  • 20-19 Tan BB06z CAR T

Trial Overview

The study is testing a new type of CAR-T cell therapy called 20-19 Tan BB06z, which targets both CD19 and CD20 proteins on cancer cells. The main goal is to find out how safe it is and what dose can be given safely.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Arm 1 - Dose EscalationExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Roswell Park Cancer Institute

Lead Sponsor

Trials
427
Recruited
40,500+

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